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See today's BioWorld Asia
Home » FDA reissues inspection interference guidance to include device manufacturing facilities
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FDA reissues inspection interference guidance to include device manufacturing facilities

Dec. 20, 2022
By Mark McCarty
The U.S. FDA has had a long-standing guidance dealing with drug manufacturing facilities that delay or deny FDA investigators’ attempts to inspect a manufacturing facility, but that policy was exclusive of device manufacturing facilities up until passage of the FDA Reauthorization Act (FDARA) of 2017. FDARA’s expansion of the policy to include device manufacturing facilities has prompted a rewrite of an existing 2014 guidance.
BioWorld Asia Regulatory U.S. FDA

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